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Specialized Quality Control & Stability Solutions for Cell Therapies

Ensure product quality with testing strategies designed for cell therapies.

Protect What Matters: Specialized Testing for Living Cell Products

Made Scientific offers comprehensive quality control testing and stability studies tailored specifically for cell therapy products. Whether that’s identity and potency measures or sterility and shelf-life, our testing strategies are designed to preserve product quality, meet regulatory standards, and support successful clinical and commercial advancement.

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Ensure Quality, Potency, and Compliance for Cell Therapies

Cell therapies demand specialized testing strategies and analytical expertise. Made Scientific provides comprehensive quality control and stability services tailored to your therapy, ensuring product integrity, regulatory compliance, and shelf-life confidence.

  • Comprehensive QC testing designed specifically for cell therapy products
  • Analytical and microbial methods for product release and characterization
  • Phase-appropriate method validation
  • Cell-specific potency and functional assay services
  • Customized ICH-compliant stability programs for shelf-life determination
  • Integrated approach and data assessment linking process development to manufacturing and product quality control

Purpose-Built Quality Control Release Testing and Stability Studies

Choose Made Scientific’s quality control and stability studies to ensure your therapy meets regulatory expectations and maintains product integrity throughout its lifecycle. Our solutions are designed for the complexity of living cellular products with flexibility, scientific rigor, and alignment from development to release.

Cell Therapy Focus

Specialized methods optimized for cellular products

Method Flexibility

Customized approaches for unique product attributes

Regulatory Alignment

Testing strategies designed to meet agency expectations

Integrated Solutions

Seamless connection between manufacturing and testing

Risk-Based Approach

Testing strategies appropriate to development stage

Stability Expertise

Customized programs for shelf-life determination and extension

Regulatory-Ready Testing for Safe, Potent, and Precise Therapies

Our quality control testing capabilities ensure your cell therapy products meet all safety, identity, purity, and potency requirements. 

Lot / Patient Batch Release Testing

  • Comprehensive identity, potency, purity, and safety testing to meet regulatory requirements
  • Advanced analytical methods, including flow cytometry, qPCR/ddPCR, ELISA, cell-based assays
  • Rapid microbiological methods, including sterility, mycoplasma, and endotoxin testing for timely product release
  • Full GMP documentation and batch record review for regulatory compliance

Safety Testing

  • Sterility testing
  • Endotoxin testing
  • Mycoplasma detection
  • Adventitious agents testing
  • Residual materials testing (antibiotics, process reagents)
  • Visual inspection

Identity Testing

  • Immunophenotyping
  • Genetic identity testing
  • Cell surface marker analysis
  • Morphological assessment

Purity Testing

  • Cell population purity
  • Viability assessment
  • Process-related impurities

Potency Testing

  • Functional cell-based assays
  • Cytokine production analysis
  • Gene expression analysis
  • Cell proliferation and activation assays

From Concept to Compliance: Method Development for Cell Therapies

Our testing experts develop, qualify, and validate methods specifically designed for cell therapy products.

  • Design of cell-specific assays addressing unique product attributes
  • Development of stability-indicating methods
  • Potency assay development appropriate to mechanism of action
  • Optimization for reproducibility, specificity, and sensitivity
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  • Phase-appropriate qualification and validation in alignment with ICH Q2(R1) guidelines
  • Analytical method robustness and accuracy assessments including specificity, linearity, precision, and range
  • Comparability and transfer studies to ensure consistency across different manufacturing sites
  • Ongoing method performance monitoring to maintain compliance and assay reliability
  • Complete documentation supporting regulatory submissions
  • Risk-based validation strategies appropriate to development stage
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The Right Tools and Technology for Every Stage

Made Scientific utilizes state-of-the-art analytical and microbiological equipment to support comprehensive cell therapy testing:

Cell Analysis Technologies

  • ChemoMetec NucleoCounter® NC-200™
  • Beckman Coulter CytoFLEX®
  • Beckman Coulter Vi-CELL BLU™
  • Thermo Fisher Scientific Varioskan™ Lux

Molecular Analysis Technologies

  • Thermo Fisher Scientific QuantStudio™
  • Bio-Rad QX200™ Droplet Digital PCR (ddPCR™)

Microbial Testing Technologies

  • Charles River EndoSafe® nexgen-PTS™
  • bioMérieux BACT/ALERT®
  • bioMérieux BioFire® FilmArray®

Environmental Monitoring

  • Viable and non-viable particle monitoring systems
  • Surface and personnel monitoring systems

End-to-End Stability Testing for Shelf-Life, Storage, and Transport

Made Scientific designs and executes stability studies to establish and verify the shelf-life of cell therapy products under various storage and handling conditions.

Stability Program Features

  • Long-term, in-use, accelerated, in-process hold-time, and shipping studies to ensure product integrity

  • Study design aligned with ICH guidelines and regulatory requirements
  • Multiple temperature conditions including intended storage and accelerated conditions
  • Stability-indicating methods detecting product degradation
  • Real-time and accelerated testing approaches
  • Comprehensive documentation and trending
  • Customized stability protocols tailored to the unique requirements of autologous and allogeneic therapies
  • Comprehensive stability protocols and reporting to support regulatory submissions

Cell Therapy Stability Storage Conditions

  • Liquid nitrogen (LN2) vapor phase 

  • Liquid nitrogen (LN2) immersion
  • Mechanical ultra-low temperature freezers
  • -80°C / -20°C / 2-8°C 
  • Ambient room temperature
  • Accelerated testing
  • Shipping simulation conditions
  • In-use conditions
  • Processing hold times
  • Additional conditions related to environmental factors

 

Stability Assessment Parameters

  • Cell viability and recovery
  • Functional activity and potency
  • Identity marker expression
  • Sterility and container closure integrity
  • Physical attributes (appearance, pH, particulates, osmolality)
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Strengthen Your Cell Therapy with Proven Quality Control and Stability

Connect with our team to design a customized testing and stability strategy tailored to your product’s biology, storage profile, and target regulatory paths.